Important note: Information in this article was accurate in October 2007. The state of the art may have changed since the publication date.
Roche withdraw application for Biojector 'needle-free' option for T-20
HIV Treatment Bulletin - Vol. 8, No. 10, October 2007
On 3 October, Roche and Trimeris announced that they are withdrawing a supplement application for approval to market Biojector B2000 as a 'needle-free' option for delivery of T-20 (enfuvirtide). [1]
The reasons for not continuing with the applications was given as 'based on comprehensive assessment of the clinical program, as well a significant delay in achieving U.S. regulatory approval due to the time required to generate additional data'.
It has been over three years since the first studies showing similar pharmacokinetics and the potential for better tolerability using Biojector compared to regular injections. [2, 3] Safety concerns in larger studies included an increased risk of nerve damage and haematoma.
Patients in the UK are not able to access Biojector as the manufacturer does not have a European license for this device.
Patients currently using Biojector in the US through an expanded safety trial may be able to continue to use the device, as it is still commercially available there.
References
2007-10-10
IB070810-10
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